Structure of an SPL Document

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SPL Header

  • Stylesheet and schema location
  • SPL identifying information
  • Labeler and manufacturing information

SPL Body

  • Product data elements
  • Product
  • Active ingredient
  • Inactive ingredient
  • Ingredient
  • Packaging
  • Accessories and components
  • Model, lot and serial number
  • Marketing category
  • Marketing status
  • DEA schedule
  • Product characteristics
  • Route of administration

Content of labeling
  • Sections and subsections
  • Labeling text
  • Font effects
  • Symbols and special characters
  • Footnotes
  • Lists
  • Tables
  • Image
  • Hypertext links
  • Recent major changes in labeling text
  • Highlights text
  • Principal Display Panel